Whitepaper: Bridging the cell and gene therapy gap
The current understanding among sponsors of the workflow from cell collection, to manufacturing, and to the clinical site for patient administration.
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The current understanding among sponsors of the workflow from cell collection, to manufacturing, and to the clinical site for patient administration.
Researchers have developed a rapid, label-free process analytical technology, called the anomaly detection model, to monitor microbial contamination in cell cultures in near-real-time.
In this issue experts explore the development of targeted protein degradation drugs, how potential legislative changes may impact the EU and selecting the right downstream process for bi-specific antibodies. Also featured in this journal, how RMM can enable efficient shutdown recovery, five critical areas for data integrity in life sciences…
Researchers suggest full evaporation static headspace gas chromatography (FE-SHSGC) could be a universal method for the analysis of semi-volatile nitrosamines in pharmaceutical products.
Study combining Raman spectroscopy with PLS-DA multivariate analysis achieves fast and non-invasive detection of contaminated drug products within vials.
Watch NSF’s complimentary 30-minute ‘expert corner’ training video on human performance with experts Catherine Kay and Julie Avery.
The new Guide from ISPE presents best practices for design, operation, maintenance and quality of membrane-based water for injection (WFI) systems.
Here, EPR summarises the key points of Tim Sandle’s recent review of mycoplasma risks, detection and eradication techniques for cell cultures.
Increasing uses of high-performance liquid chromatography (HPLC) and rising healthcare investment driving market growth, finds report.
How the pharma industry can tackle the shortage of QPs by Lynne Byers, Senior Director Pharma Consulting, NSF Health Sciences.
Modern technology for signal detection and signal management in PV is pivotal to ensure the patient’s safety.
Single use technologies is highly booming in biopharmaceutical sector due to its efficient use and benefits.
The PyroCell® Monocyte Activation Test - Human Serum System (PyroCell® MAT HS System) provides more sensitive detection of non-endotoxin pyrogen contaminants in pharmaceutical preparations.
Here, EPR discusses critical considerations to ensure content uniformity in HPAPI drugs produced using dry techniques.
Researchers have identified, for the first time, a sensitive, low-risk, closed-system for the detection of fungal contaminants in cell and gene therapy (CGT) products.